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FDA 510(k)

ACRYL-X SYSTEM TM

K-Number: K911548 · 1991-06-28

ApplicantSonokinetics, Inc.
Decision Date1991-06-28
Product CodeJDX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACRYL-X SYSTEM TM is the device name listed in this FDA 510(k) record. The listed applicant is Sonokinetics, Inc.. It received FDA 510(k) clearance on 1991-06-28 under 510(k) number K911548. The device is classified under product code JDX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACRYL-X SYSTEM TM?

ACRYL-X SYSTEM TM is a medical device that received FDA 510(k) clearance on 1991-06-28. The listed applicant is Sonokinetics, Inc.. The 510(k) number is K911548.

When did ACRYL-X SYSTEM TM receive FDA 510(k) clearance?

ACRYL-X SYSTEM TM received FDA 510(k) clearance on 1991-06-28, under 510(k) number K911548.

Who is the listed applicant for ACRYL-X SYSTEM TM?

The FDA 510(k) record lists Sonokinetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACRYL-X SYSTEM TM?

The FDA product code for ACRYL-X SYSTEM TM is JDX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Sonokinetics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K990572SONOTOMEK930629ACRYL-X II SYSTEM

Related Devices (Code: JDX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201274Ultrasonic Osteotomy Surgical SystemSmtp Technology Co., Ltd.K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research ConsortiumK163610PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon GroupK153743PIEZOSURGERY PLUSMectron S.P.A.K132848PIEZOSURGERY FLEXMectron S.P.A.K100410PIEZOELECTRIC SYSTEMSatelec

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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